Month: February 2022

Clare Love, Robert Sachs and Eric Sawyer respond to Astellas Feb 9 Statement on Xtandi Bayh Dole march in and government use case

Posted on by James Love

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This is a letter from the three prostate cancer patient petitioners to HHS Secretary Becerra and Acting NIH Director Tabak, regarding the February 9, 2020 statement by Astellas on the Bayh-Dole march in and government rights case. The patient’s letter…

USTR and the Trade Policy Staff Committee (TPSC) submit questions to groups that provided USTR Special 301 comments

Posted on by James Love

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The Special 301 Subcommittee of the Trade Policy Staff Committee has sent a document with questions to everyone who provided comments on the Special 301 list. The questions are attached and are also available at https://www.regulations.gov/comment/USTR-2021-0021-0065. The deadline to submit…

Senators Warren and King, and Representative Doggett ask HHS Secretary Becerra to Move Forward on Xtandi March-in and Government Use Rights (Existing Bayh-Dole Safeguards)

Posted on by James Love

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Senators Elizabeth Warren (D-MA) and Angus King (I-ME) and Representative Lloyd Doggett (D-TX) wrote Secretary of HHS Xavier Becerra on February 17, 2022, urging him to move forward with the march-in petition by Robert Sachs, Clare Love and Eric Sawyer,…

KEI Reaction to Astellas Comment Regarding Public and Private Sector Contributions to the Development of Xtandi

Posted on by James Love

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(More on the Xtandi case here: https://www.keionline.org/xtandi2021) Astellas has issued a statement, dated February 9, 2022, on the Bayh-Dole Act and the petition to exercise march-in and government use rights in the prostate cancer drug Xtandi. It was brought to…

KEI Comments to NIH on Exclusive License to TeraImmune for T-cell Therapy for Multiple Sclerosis

Posted on by KEI Staff

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(Update: The NIH provided a response to our questions and comments on February 28, 2022) On February 9, 2022, Knowledge Ecology International (KEI) filed comments with the National Institutes of Health regarding the “Prospective Grant of Exclusive Patent License: Development…

Senator Tillis Letter to FDA and USPTO Asking for a Study of Relationship between Patents and Drug Prices

Posted on by James Love

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In a January 31, 2022 letter to Drew Hirshfeld, the Commissioner for Patents for the USPTO, and Janet Woodcock, the Acting Commissioner of the FDA, Senator Thom Tillis provides extensive criticism of the empirical work of the group I-MAK and…

Xtandi Petitioners Highlight Pfizer Practice of Reference Pricing in US Government Contracts

Posted on by Claire Cassedy

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Following the publication of the US government contract with Pfizer for the COVID-19 therapeutic Paxlovid, the petitioners of the Xtandi government use request wrote to the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH)…

Robert H. Mermell Letter of Support for Government Use Request on Prostate Cancer Drug Xtandi

Posted on by Claire Cassedy

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The Department of Health and Human Services (HHS) and National Institutes of Health (NIH) is currently reviewing whether to proceed with the request that the government use its rights in the prostate cancer drug Xtandi, in order to enable generic…

Harvard academics letter supporting use of US government rights in Xtandi patents to remedy price discrimination against US residents

Posted on by Claire Cassedy

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On February 2, 2022, Drs. Ameet Sarpatwari, Aaron S. Kesselheim, Jerry Avorn, and Benjamin N. Rome of Harvard Medical School and Dr. Michael S. Sinha of Northeastern University and Loyola University sent a letter to HHS Secretary Xavier Becerra in…

PhRMA targets WHO, WIPO, WTO, UNDP, UNCTAD, Unitaid, and WTO in comments to the USTR’s Special 301 report for 2022

Posted on by Thiru

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On 13 December 2021, the Office of United States Trade Representative (USTR) posted the following request for public comment in relation to its 2022 Special 301 Review: Identification of Countries Under Section 182 of the Trade Act of 1974 noting…